Clinical testing and characterization of plasma-derived hepatitis B vaccine prepared by the NIAID will soon be completed. The vaccine is highly immunogenic, safe and well tolerated. An efficacy trial of the vaccine in infants is in progress in Asia. Second generation hepatitis B vaccines are currently under development. Approaches include the use of recombinant DNA-derived viral antigen and synthetic peptides. Preliminary results of the former are encouraging; preliminary results with the latter suggest that problems associated with immunogenicity must be overcome before synthetic peptide vaccines for hepatitis B will be practical.